Ipana 20% Benzocaine Topical

Product NDC: 69510-352
11-digit product format: 695100352
Labeler code: 69510
Product ID: 69510-352_462b9b39-e937-5526-e063-6294a90a776c
Type: HUMAN OTC DRUG
Nonproprietary name: Benzocaine
Dosage form: GEL
Route: DENTAL
Labeler: Maxill Inc.
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-08-01
Substance: BENZOCAINE
Active strength: 200 mg/g
Pharmacologic classes: Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69510-352		D	Discontinued by firm		2026-10-15
excluded package	package	69510-352	69510-352-28	D	Discontinued by firm		2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69510-352-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69510-352-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69510-352-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69510-352-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69510-352-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69510-352-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69510-352-28	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69510-352-28	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69510-352-28	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69510-352-28	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69510-352-28	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69510-352-28	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Ipana 20% Benzocaine Topical
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZOCAINE	200 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U3RSY48JW5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
238910	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9de36e4f-f966-4a58-b4bf-9ac3b86b3f09	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69510-352-30	Ipana 20% Benzocaine Topical	28 g in 1 JAR	GEL	28		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69510-352	IPANA 20% BENZOCAINE TOPICAL (BENZOCAINE) GEL [MAXILL INC.]	8	Current NDC, Legacy NDC, 1 package rows	20241018_9de36e4f-f966-4a58-b4bf-9ac3b86b3f09.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 18 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Listerine Essential Care	SODIUM MONOFLUOROPHOSPHATE	Kenvue Brands LLC	90b5c3d8-baa4-44ab-8f73-e177007f0219	2025-10-10	Warnings	Exact identifier application number: M022
DuoCare Clinical Oral Rinse	CETYLPYRIDINIUM CHLORIDE	Medline Industries, LP	98e61cd5-7e29-7066-e053-2a95a90afa21	2025-10-10	Warnings	Exact identifier application number: M022
4-in-1 Teeth Care Pens	4-IN-1 TEETH CARE PENS	Jiangxi Dentalbright Technology Co., Ltd	40b756b7-ce1b-6482-e063-6294a90a0425	2025-10-09	Warnings	Exact identifier application number: M022
Giltuss Bucalsep	BENZOCAINE, MENTHOL, ZINC CHLORIDE	Gil Pharmaceutical Corp	85053391-8d71-ab4f-e053-2991aa0a7e08	2025-10-09	Warnings	Exact identifier application number: M022
Listerine Gum Therapy Mouthwash Glacier Mint	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	40a0bdf3-1698-1449-e063-6394a90ab13d	2025-10-08	Warnings	Exact identifier application number: M022
Kalaya Breath Refresh	MOUTHWASH	Avaria Health and Beauty Corp	750e99ff-72e4-3c2f-e053-2a91aa0ad5a0	2025-10-08	Warnings	Exact identifier application number: M022
Trader Joes	SODIUM FLUORIDE 0.24% AND POTASSIUM NITRATE 5%	TRADER JOE'S COMPANY	159abeba-6da2-2643-e063-6394a90a730d	2025-10-08	Warnings	Exact identifier application number: M022
Family Wellness Oral Pain Relief	BENZOCAINE 20%	FAMILY DOLLAR SERVICES INC	105d87d6-9147-43d4-e063-6394a90a57ee	2025-10-08	Warnings	Exact identifier application number: M022
Equate Glistening Mint	SODIUM FLUORIDE	Walmart Inc.	39ff21ee-a362-014e-e063-6294a90a0d91	2025-10-03	Warnings	Exact identifier application number: M022
Mouth Sore Relief Professional Strength	BENZOCAINE	CVS Pharmacy	1b7209f6-8368-47fa-8df2-b049613b8c1b	2025-09-30	Warnings	Exact identifier application number: M022
Hydrogen Peroxide	HYDROGEN PEROXIDE	Family Dollar (FAMILY WELLNESS)	9db73da2-5b70-41e6-bcf9-caa7f1142024	2025-09-29	Warnings	Exact identifier application number: M022
Esunix Oral Bacteriostatic Liquid	CETYLPYRIDINIUM CHLORIDE	Xiling (Zhenjiang) Medical Technology Co., Ltd.	3f47d7e1-b6ae-efd1-e063-6394a90a4602	2025-09-27	Warnings	Exact identifier application number: M022
Chloraseptic Sore Throat Cherry	PHENOL	Prestige Brands Holdings, Inc.	d5d62f7a-8f92-4d42-a2fb-691f896f72fc	2025-09-26	Warnings	Exact identifier application number: M022
Giltuss Bucalsep	BENZOCAINE, MENTHOL, ZINC CHLORIDE	Dextrum Laboratories Inc.	3fa233dc-156c-1e95-e063-6294a90a8bbd	2025-09-25	Warnings	Exact identifier application number: M022
Finafta MultiOral	BENZOCAINE	Dextrum Laboratories Inc.	cb027ab8-4175-4cc0-a73e-991dfb113df9	2025-09-23	Warnings	Exact identifier application number: M022
4-in-1 Teeth Care Pens	4-IN-1 TEETH CARE PENS	Jiangxi Dentalbright Technology Co., Ltd	3f872924-0c44-267b-e063-6394a90a1a67	2025-09-23	Warnings	Exact identifier application number: M022
Dental Relief	BENZOCAINE	Cintas Corporation	0f40f775-797e-43cf-88c9-00eea666494f	2025-09-23	Warnings	Exact identifier application number: M022
Seavue Anti-caries Gel	SODIUM FLUORIDE	Xiling (Zhenjiang) Medical Technology Co., Ltd.	3f4c6086-b96d-8fa4-e063-6294a90ad800	2025-09-21	Warnings	Exact identifier application number: M022
Seavue Dental Desensitizer	POTASSIUM NITRATE AND SODIUM FLUORIDE DENTIFRICE	Xiling (Zhenjiang) Medical Technology Co., Ltd.	3f47f399-1a14-5264-e063-6394a90aeb1c	2025-09-20	Warnings	Exact identifier application number: M022
Povi-One	POVIDONE-IODINE 10% TOPICAL	Elevate Oral Care	27c29a33-d1cc-d72f-e063-6394a90a4d45	2025-09-19	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3RSY48JW5	BENZOCAINE	94-09-7	BENZOCAINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
238910	benzocaine 20 % Oral Gel	PSN	9de36e4f-f966-4a58-b4bf-9ac3b86b3f09	9
238910	benzocaine 0.2 MG/MG Oral Gel	SCD	9de36e4f-f966-4a58-b4bf-9ac3b86b3f09	9
238910	benzocaine 20 % (180-220 MG per 1 GM) Oral Gel	SY	9de36e4f-f966-4a58-b4bf-9ac3b86b3f09	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69510-352-30	69510035230	28 g in 1 JAR (69510-352-30)	28 g	2016-08-01	0000-00-00	No	No	Current